About the role
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. Team Description: Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function. We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products. Job Description and
Responsibilities: Please note, this is a duplicate posting for the "Quality Systems Engineer" role. We are testing titling to see which attracts the most qualified candidates. Please only apply to one of the postings. As a Software Design Controls Engineer, your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture. You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from
requirements definition through verification, validation, risk management, and release. You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your
responsibilities include, but are not limited to: Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control